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PSMA-PET Scan for Prostate Cancer

Phase 2 & 3
Recruiting
Led By Kosj Yamoah, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
Age > 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will follow patients who had high-risk results on a previous study to see if they benefit from additional testing and treatment recommendations.

Who is the study for?
Men over 18 with high-risk prostate cancer, as indicated by a Decipher test score greater than 0.45, who were part of a previous study (MCC#18523) and have had either surgery or radiation therapy for their cancer. They must be in good physical condition (ECOG status 0-1) and have at least two years of follow-up data post-treatment.Check my eligibility
What is being tested?
The trial is testing PSMA-PET imaging using F-DCFPyL injection to detect early metastatic prostate cancer in men with high genomic classifier scores from an earlier study. The goal is to see how well this imaging technique works for those at higher risk.See study design
What are the potential side effects?
While the document does not specify side effects, generally PET scans are considered safe; however, there may be risks related to allergic reactions to the tracer substance or discomfort from lying still during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My biopsy or surgical sample has undergone genomic testing.
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I am older than 18 years.
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My Decipher score is above 0.45, indicating high risk.
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I had surgery or radiation for prostate cancer over 2 years ago, with or without hormone therapy.
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I was part of MCC#18523 and my Decipher score is above 0.45.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Secondary outcome measures
Rate of Positive PSMA-PET Findings

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radioactive Diagnostic ImagingExperimental Treatment2 Interventions
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.

Find a Location

Who is running the clinical trial?

Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,298 Total Patients Enrolled
17 Trials studying Prostate Cancer
1,732 Patients Enrolled for Prostate Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
546 Previous Clinical Trials
135,532 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,124 Patients Enrolled for Prostate Cancer
Kosj Yamoah, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
284 Total Patients Enrolled
2 Trials studying Prostate Cancer
284 Patients Enrolled for Prostate Cancer

Media Library

PSMA PET Clinical Trial Eligibility Overview. Trial Name: NCT03495427 — Phase 2 & 3
Prostate Cancer Research Study Groups: Radioactive Diagnostic Imaging
Prostate Cancer Clinical Trial 2023: PSMA PET Highlights & Side Effects. Trial Name: NCT03495427 — Phase 2 & 3
PSMA PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT03495427 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the target condition able to enroll in this research project at this time?

"Yes, this trial is currently looking for enrolment. According to the listing on clinicaltrials.gov, the study was first posted on December 18th, 2019 and was last updated on August 18th, 2022."

Answered by AI

How many people are being given the chance to participate in this research?

"That is correct. As of August 18th, 2022, the study detailed on clinicaltrials.gov was still recruiting patients that it first posted about on December 18th, 2019. Currently, only 1 location is being used to screen the 60 participants needed for the trial."

Answered by AI
~0 spots leftby Jun 2024